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临床试验/NCT04193280
NCT04193280Unknown不适用

Does Blood Sugar Level Affect Postoperative Agitations in Outpatient Pediatric Surgery?

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Blood sugar level

研究概览

简要总结

The aim of this study is to investigate the effect of fasting time and blood glucose levels on postoperative agitations in pediatric patients who will undergo outpatient surgery.

详细描述

Emergence delirium is a very important clinic phenomenon, characterized by irritability and severe restlessness in children recovering from anesthesia; it may cause injury to the child recovering from anesthesia or to surgical site and may also lead to parents, who witness emergence delirium to question the quality of anesthesia. Postoperative agitaitons, has been noted with the newer, less soluble inhaled agents and emergence delirium has become a serious problem, taken care in postanesthesia care unit for anesthesiologists. Preoperative anxiety, premedication, anesthetic drugs, pain, type of surgery and emergence in a foreign environment are the factors which take part in the development of emergence delirium. Emotional and less social children, the children with anxious parents, children undergoing upper airway surgery are under risk. Detection of children at risk, the use of appropriate adjuvant drugs, strict control of postoperative pain, and accompanying parents to their children in the recovery room are currently the primary measures to prevent recovery agitation. Further studies are required to discover underlying causes and management of emergence delirium.

In this study pre-and postoperative blood glucose values, preoperative fasting times and hemodynamic values of 200 American Society of Anesthesiologists (ASA) physical status I-2 patients will be recorded. At the end of the operation, patients will be evaluated with Modified Aldrete Sedation Scale, FLACC Pain Rating Scale and PAED Agitation Scale. The results obtained will be evaluated with statistical methods and the relationship between preoperative fasting time and blood glucose levels and postoperative agitations will be investigated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Months 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients between 2-12 years of age who will undergo outpatient surgery

排除标准

  • ASA III-IV patients, patients with congenital malformation and developmental delays, or any neurological or cardiac diseases

结局指标

主要结局

Blood sugar level

时间窗: 11.1.2019-5.31.2020

Blood glucose levels will be measured in pediatric patients who will undergo outpatient surgery.

The fasting time

时间窗: 11.1.2019-5.31.2020

Fasting time will be recorded.

The change in blood sugar level

时间窗: 11.1.2019-5.31.2020

According to the type of operation, the change in blood sugar level will be detected. Correlation of this change with postoperative agitation will be investigated

次要结局

未报告次要终点

研究者

发起方
Istanbul Medeniyet University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeynep Nur Orhon

Principal Investigator

Istanbul Medeniyet University

研究点 (1)

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